1. Internal medicine physicians call for improved access and quality in health care for incarcerated patients
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Note: Sound bites from ACP President Ryan Mire, MD, MACP available for download at https://www.dssimon.com/MM/ACP-Incarceration
Adequately funded policies and procedures are needed to reduce health care disparities in access to, and quality of, health care for the U.S. jail and prison population says the American College of Physicians (ACP). Health Care During Incarceration: A Policy Position Paper of the American College of Physicians details recommendations to improve the health and wellbeing of individuals incarcerated in adult correctional facilities. The paper is published in Annals of Internal Medicine.
ACP’s recommendations include adequate funding for, and timely access to, necessary health care services that are evidence-based and meet community standards. They also recommend measures to ensure adequate nutrition; opportunity for physical activity; smoke-free policies and smoking cessation interventions; and access to recommended preventive health services. ACP further calls for policies to adequately treat both chronic noncommunicable diseases and infectious diseases. This should include infectious disease prevention and control programs developed with public health authorities. In addition, all persons entering correctional facilities should be screened for substance use disorders and behavioral health conditions and provided with treatment if necessary. ACP also supports policies that promote the treatment of patients with substance use disorders as an alternative incarceration.
The paper also details recommendations for population segments within correctional facilities. This includes recommendations for how to better meet the needs of incarcerated women; LGBTQ+ patients; aging patients and those living with disabilities or life-limiting illnesses; and immigrant populations.
Lastly, the paper details how health care needs must be included in community re-entry planning for individuals who are released from jail or prison, so that they are able to continue to access health care and social services once they return to their communities. ACP specifically makes recommends for policies that would help to facilitate or reinstate state Medicaid enrollment.
Media contacts: For an embargoed PDF, please contact Angela Collom at [email protected] To speak with someone from ACP, please contact Jaquelyn Blaser at [email protected]
2. Climate change contributing to an expected rise in fungal pathogens over the next decade
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Endemic mycoses, or fungal pathogens that lead to a wide range of diseases in humans, are expected to become more common in the coming decade, partly due to climate change. The increasing spread of these pathogens increases the possibility that clinicians without familiarity of the mycoses may encounter them in daily practice. This is important because endemic mycoses may be erroneously diagnosed as bacterial infections, leading to inappropriate use of antibiotics and other prescriptions that provide no relief to the patient. The commentary is published in Annals of Internal Medicine.
Stopping the spread of fungal pathogens is a public health priority being increasingly recognized by international public health efforts. In October 2022, the World Health Organization (WHO) announced the creation of the WHO fungal priority pathogens list (WHO FPPL), a new effort to “systematically prioritize fungal pathogens, considering their unmet research and development (R&D) needs and perceived public health importance.”
Authors from the University of California-Davis and the Centers for Disease Control and Prevention highlight the increasing spread of blastomycosis, coccidioidomycosis, and histoplasmosis, the endemic mycoses that are most prevalent in North America. All three pathogens have been traced outside of their original endemic regions due to both climate change and more thorough identification. The authors highlight the current lack of guidelines for testing and treatment of mycoses, unlike when clinicians encounter infections like community-acquired pneumonia. Patients who have been infected with these pathogens may experience long periods of illness between initial infection and diagnosis, leading to increased healthcare costs and frequent antibiotic overprescription. The authors say that improvements in our epidemiologic understanding of disease and the ability to capture changes in disease incidence at the county level would enable directed educational efforts, public health campaigns, and quality improvement initiatives to reduce the time to diagnosis and receipt of appropriate antifungal therapy.
Media contacts: For an embargoed PDF, please contact Angela Collom at [email protected] To speak with the corresponding author, George R. Thompson III, MD, please contact Nadine Yehya, PhD, MBA at [email protected]
3. More than half of pivotal FDA trials recruit from lower middle income countries, but country enrollment is rarely reported
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An analysis of 144 pivotal trials for U.S. Food and Drug Administration (FDA)-approved medications in cancer, cardiovascular disease, and neurology has found that more than half of the studies recruit patients from low- and middle-income countries (LMIC). However, available country data for trials are sparse, contributing to problems with both study verification and participant recruitment ethics. The analysis is published in Annals of Internal Medicine.
Drugs sold in North America are often tested abroad, including LMICs. Recruitment from LMICs for trials intended to inform North American health care has scientific and ethical implications. Drug effects can vary because of geographic differences in patient baseline characteristics, diet, and comorbid conditions. Recruitment in LMICs also raises ethical issues. Trials require extra clinic visits, procedures, and exposure to unproven treatments, including unknown risks. The FDA does not require sponsors to report or publicly disclose which countries participants are recruited from.
Researchers from the Department of Equity, Ethics and Policy, McGill University, conducted a cross-sectional analysis of 66 new drugs and 144 pivotal clinical trials. The authors evaluated 29 approved cardiovascular trials, 26 approved neurologic trials, and 61 approved cancer trials. They found that among all analyzed trials, 56 percent in cancer, 79 percent in cardiovascular disease, and 56 percent in neurology recruited from LMICs. The authors also report that country-level enrollment figures were not available for 55 percent of multi-country trials. According to the authors, although recruitment is often reported by region or continent, such groupings can obscure important differences among host countries. They emphasize that sporadic availability of country enrollment can frustrate the valid interpretation of pivotal trial findings. It can also limit the ability to monitor and hold research sponsors accountable for fair participant selection. They urge journals, regulators, and ClinicalTrials.gov to establish policies that require public reporting of country-level information on recruitment.
Media contacts: For an embargoed PDF, please contact Angela Collom at [email protected] To speak with corresponding author Jonathan Kimmelman, PhD, email [email protected]